The regulator inspected the company’s Unit-VII plant located in Jedcherla, which manufactures oral solid dosage formulations. Following the inspection, the USFDA issued a Form 483 with nine observations, pointing to deficiencies across critical quality and compliance systems.
According to the inspection findings, investigators noted shortcomings in the way quality investigations were handled, stating that root cause analyses were not always scientifically robust. In several instances, out-of-specification (OOS) results were reportedly closed without adequate justification, raising concerns about analytical discipline and compliance with established procedures.
The observations covered various operational aspects including production systems, laboratory controls, employee training, and quality assurance mechanisms. Inspectors flagged incomplete and inconsistent batch manufacturing records and questioned whether manufacturing deviations were properly assessed for their potential impact on product quality.
The USFDA also identified lapses in cleaning validation procedures and equipment maintenance documentation, suggesting weaknesses in operational controls. Environmental monitoring practices within manufacturing areas were found to be inadequate, indicating that controlled conditions were not consistently maintained.
Further, inspectors highlighted contamination risks at the facility. Observations included residue accumulation in non-dedicated HVAC and HEPA systems, as well as reports of microbial contamination such as Pseudomonas and E. coli detected in filter housings and ductwork. Instances of bird droppings, dust and other unsanitary conditions were also cited during the inspection.
Data integrity concerns formed another key part of the regulator’s findings. The USFDA raised issues about insufficient data governance and weak access controls in laboratory systems, potentially allowing unauthorized data modifications.
The inspection was conducted between January 28 and February 10 and culminated in the issuance of the Form 483, reports NDTV Profit. While a Form 483 does not immediately trigger enforcement action, the company is required to submit a detailed response outlining corrective and preventive measures to address the observations.
Following the disclosure, Aurobindo Pharma’s shares came under pressure as investors reacted to the heightened regulatory scrutiny. Market participants are now closely watching the company’s response and any subsequent action from the US regulator.
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